Individual Sensitivity for Interstitial Lung Diseases

NCT ID: NCT00741572

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-09-30

Brief Summary

Interstitial lung diseases (ILD) is a collective noun for various chronic lung diseases, including sarcoidosis and idiopathic lung fibrosis (IPF). Sarcoidosis is a multi-systemic disease that includes damage to the lungs in 90% of the patients. Generally, the disease can be described as a systemic, granulomatous and antigen-driven disorder. IPF is a disease of only the lungs, in which an unknown cause induces a strong inflammation reaction leading to acute lung damage that ultimately results in the formation of scar tissue and stiffness of the lungs.

Unfortunately, the exact cause of ILD is still unknown. It is suggested that environmental and work-related exposure to various triggers can exert an effect on the course of the diseases. Examples of such triggers include bacteria, organic agents such as pollen and cotton dust and inorganic agents like metals and talc. Due to this unknown cause, it is difficult to treat ILD. Consequently, the current guideline is no medication or anti-inflammatory agents in severe cases. Unfortunately, this therapy is not completely effective.

Triggers that are suggested to cause ILD can exert their effects via various mechanisms. On the one hand, they can induce an inflammatory reaction as we recently demonstrated for various triggers including instillation material and sicila. During such an inflammatory reaction, cytokines are released that can induce oxidative stress, i.e. an imbalance between the formation of and the protection against reactive oxygen species (ROS). On the other hand, ILD-inducing triggers may directly cause an increased ROS production that subsequently can evoke an inflammatory reaction.

The objective of the current study is to investigate the individual sensitivity for the development of ILD after exposure to various triggers. Main focus will be the differences in the formation of and the protection against ROS as well as the occurring inflammatory reaction after exposure to such triggers.

Furthermore, a simple blood test will be developed to study and eventually even predict the individual reaction of subjects to various triggers.

Finally, to fully characterize the development of ILD after exposure to various triggers, the exhaled air of patients will be studied in order to identify specific markers of oxidative stress and damage.

Conditions

Interstitial Lung Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

No interventions assigned to this group

2

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• ILD diagnosis confirmed by lung biopsy, X ray or BALF analysis

Exclusion Criteria

• smoking
• pregnancy or lactation
• use of vitamins or nutritional supplements

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Maastricht University

Principal Investigators

Aalt Bast, PhD

Role: STUDY_CHAIR

Maastricht University

Marjolein Drent, PhD, MD

Role: STUDY_DIRECTOR

Maastricht University Medical Center

Agnes W Boots, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University

Maastricht, , Netherlands

Countries

Netherlands

References

Fijten RRR, Smolinska A, Drent M, Dallinga JW, Mostard R, Pachen DM, van Schooten FJ, Boots AW. The necessity of external validation in exhaled breath research: a case study of sarcoidosis. J Breath Res. 2017 Nov 29;12(1):016004. doi: 10.1088/1752-7163/aa8409.

Reference Type: DERIVED

PMID: 28775245 (View on PubMed)

Related Links

http://www.ildcare.eu

Related Info

Other Identifiers

MEC 08.3.048

Identifier Type: -

Identifier Source: org_study_id